US EPA

8307550 

Journal Article 

A quantitative estimation and validation of Atorvastatin Calcium and Pioglitazone in tablet dosage Form by hydrotropic solubilization phenomenon 

Sharma, S; Sharma, MC 

2010 

2 

4 

2487-2491 

English 

Various organic solvents like methanol, chloroform, alcohol, dimethyl formamide; acetonitrile, hexane, acetone and carbon tetrachloride have been employed for solubilization of poorly water-soluble drugs for spectrophotometric estimations. Drawbacks of organic solvents include higher cost, toxicity and error in analysis due to volatility. Attempting to minimize these drawbacks, three new, simple, accurate, environmental friendly, cost effective, safe, sensitive spectrophotometric methods have been developed for simultaneous estimation of Atorvastatin Calcium (ATV) and Pioglitazone (PIO) in tablet dosage form tablet dosage form using 8.0 M sodium benzoate aqueous solution, as a hydrotropic agent. Aqueous solubility of these model drugs were enhanced to a great extent 55 and 71 fold for Atorvastatin Calcium (ATV) and Pioglitazone (PIO) in 8.0M sodium benzoate solution respectively. Sodium benzoate solution and additives of tablet did not interfere in analysis, as sodium benzoate did not show any absorbance above 300nm. In 8.0M sodium benzoate solution, Atorvastatin Calcium (ATV) and Pioglitazone (PIO) in tablet dosage form shows maximum absorbance at wavelength 313.0 nm and 324 nm respectively and isobestic point was observed at 303 nm. Beer's law was obeyed in the concentration range 5-35 μg/ml for Atorvastatin Calcium and 5-40μg/ml for Pioglitazone. Method-I is based on simultaneous equation method Results of analysis for methods were tested and validated for various parameters according to ICH guidelines, hence can be adopted for the routine analysis of Atorvastatin Calcium (ATV) and Pioglitazone (PIO) in tablet dosage form. 

Atorvastatin Calcium; Hydrotropic Solubilization; Pioglitazone HCl; Simultaneous equation method